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Improving REsectability in Pancreatic NEoplasms (IRENE) (IRENE)

Primary Purpose

Pancreatic Cancer, Stereotactic Body Radiotherapy

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SBRT plus chemotherapy
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, stereotactic body radiotherapy, resectability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • histological diagnosis of locally advanced pancreatic carcinoma, not upfront surgically treated (according to NCCN resectability criteria), without distant metastases
  • NCCN criteria resectability status
  • patient's age, performance status, possible presence of comorbidity should also be considered to decide the optimal approach (upfront surgery versus neoadjuvant treatment).
  • If the chemotherapy treatment induces the disease to a condition of resectability, the patient will undergo a surgical evaluation
  • indication for radiotherapy treatment
  • ECOG 0-2
  • obtaining informed consent
  • not pregnant or breastfeeding

Exclusion Criteria:

  • ECOG> 2
  • presence of internal diseases for which radiotherapy is contraindicated, or diseases of the connective system, or gastric or duodenal ulcer in progress or acute diverticulitis, ulcerative colitis
  • comorbidity which in the opinion of the referring physician may constitute a risk for participation in the study
  • lack of availability for clinical-instrumental follow-up
  • previous abdominal radiotherapy.

Sites / Locations

  • Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT plus chemotherapy

Arm Description

Patients with unresectable or "borderline resectable" locally advanced pancreatic carcinoma at time of diagnosis

Outcomes

Primary Outcome Measures

Clinical response to the treatment in terms of resectability
Percentage of patients with pancreatic cancer judged to be inoperable who have undergone surgical treatment after neoadjuvant chemotherapy plus stereotactic body radiotherapy. Response is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria) by a multidisciplinary team of surgeons, radiologist, oncologist, radiation oncologist according to resectability criteria NCCN v. 2017.

Secondary Outcome Measures

Overall survival
Months of survival since the diagnosis
Progression free survival
Progression-free survival (PFS) after radiotherapy is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria). Also laboratory tests are performed (CA 19.9)
Toxicity
Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03
Quality of life
QoL are assessed with Cancer Linear Analog Scale (CLAS) which evaluating well-being, fatigue, and ability to perform daily activities (values range from 0 that represents the best status to 10 that represents the worst one)

Full Information

First Posted
March 5, 2018
Last Updated
May 28, 2018
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT03460925
Brief Title
Improving REsectability in Pancreatic NEoplasms (IRENE)
Acronym
IRENE
Official Title
Interventional Multicentric Study Without Medicine, in Patients Affected by Locally Advanced Pancreatic Adenocarcinoma: Stereotactic Radiotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Evaluation of clinical response in terms of resectability of patients with locally advanced pancreatic cancer treated with neoadjuvant chemotherapy plus stereotactic body radiotherapy.
Detailed Description
Aim of the study is to define the percentage of patients with down-staging and clinical response after having undergone stereotactic radiotherapy + chemotherapy with neoadjuvant intent for locally advanced pancreatic carcinoma or "borderline resectable" at the time of diagnosis. The study evaluates the response to therapy in terms of resectability, of acute and delayed treatment-related toxicity, of overall survival and progression-free survival and also assesses patient's quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Stereotactic Body Radiotherapy
Keywords
pancreatic cancer, stereotactic body radiotherapy, resectability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBRT plus chemotherapy
Arm Type
Experimental
Arm Description
Patients with unresectable or "borderline resectable" locally advanced pancreatic carcinoma at time of diagnosis
Intervention Type
Radiation
Intervention Name(s)
SBRT plus chemotherapy
Intervention Description
Neoadjuvant stereotactic body radiotherapy (SBRT, 30 Gy in 5 fractions) plus chemotherapy with Folfirinox
Primary Outcome Measure Information:
Title
Clinical response to the treatment in terms of resectability
Description
Percentage of patients with pancreatic cancer judged to be inoperable who have undergone surgical treatment after neoadjuvant chemotherapy plus stereotactic body radiotherapy. Response is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria) by a multidisciplinary team of surgeons, radiologist, oncologist, radiation oncologist according to resectability criteria NCCN v. 2017.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Months of survival since the diagnosis
Time Frame
24 months
Title
Progression free survival
Description
Progression-free survival (PFS) after radiotherapy is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria). Also laboratory tests are performed (CA 19.9)
Time Frame
24 months
Title
Toxicity
Description
Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03
Time Frame
24 months
Title
Quality of life
Description
QoL are assessed with Cancer Linear Analog Scale (CLAS) which evaluating well-being, fatigue, and ability to perform daily activities (values range from 0 that represents the best status to 10 that represents the worst one)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histological diagnosis of locally advanced pancreatic carcinoma, not upfront surgically treated (according to NCCN resectability criteria), without distant metastases NCCN criteria resectability status patient's age, performance status, possible presence of comorbidity should also be considered to decide the optimal approach (upfront surgery versus neoadjuvant treatment). If the chemotherapy treatment induces the disease to a condition of resectability, the patient will undergo a surgical evaluation indication for radiotherapy treatment ECOG 0-2 obtaining informed consent not pregnant or breastfeeding Exclusion Criteria: ECOG> 2 presence of internal diseases for which radiotherapy is contraindicated, or diseases of the connective system, or gastric or duodenal ulcer in progress or acute diverticulitis, ulcerative colitis comorbidity which in the opinion of the referring physician may constitute a risk for participation in the study lack of availability for clinical-instrumental follow-up previous abdominal radiotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessio G Morganti, MD
Phone
+390512143564
Email
rt.unibo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Organizational Affiliation
Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
Official's Role
Study Director
Facility Information:
Facility Name
Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Phone
+390512143564
Email
rt.unibo@gmail.com
First Name & Middle Initial & Last Name & Degree
G

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Improving REsectability in Pancreatic NEoplasms (IRENE)

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